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US FDA collaborating with international agencies to understand the extent of cough syrup contamination

The U.S. Food and Drug Administration (FDA) is working closely with regulatory authorities in other countries to learn more about the scope of contamination in a cough syrup made by a Chinese manufacturer. In August, the FDA issued a warning letter to Zhejiang Huahai Pharmaceuticals Co., Ltd. after identifying a potential contamination of the active pharmaceutical ingredient in the company’s ranitidine products, which are used in over-the-counter and prescription versions of the drug. The FDA has requested that the company provide additional information on the scope of the potential contamination.

The FDA is closely monitoring the situation and is in contact with regulatory authorities in other countries to share information and coordinate regulatory action. The FDA is also working with manufacturers to ensure that the ranitidine products available in the United States are safe and effective for their intended use.